• In January 2025, Sanofi launched a Phase II clinical trial for its novel biologic therapy targeting thyroid-stimulating immunoglobulins (TSI) in patients with Graves disease. This initiative marks a significant milestone in the advancement of monoclonal antibody-based therapies for autoimmune thyroid disorders. By directly neutralizing TSIs, the therapy aims to prevent hyperthyroid flares and minimize relapse rates, offering a targeted treatment alternative to standard antithyroid medications and surgery.
• In August 2024, Novartis entered a strategic collaboration with a leading AI diagnostics firm to jointly develop early screening tools for autoimmune thyroid diseases, including Graves disease. The initiative focuses on leveraging machine learning algorithms and clinical biomarker integration to enhance the accuracy and speed of diagnosis. The partnership is expected to support data-driven therapeutic planning, paving the way for more personalized and predictive approaches in thyroid disease management.
• In November 2023, Merck announced that the European Medicines Agency (EMA) granted approval for its extended-release pediatric formulation of methimazole, a frontline antithyroid drug. This innovation addresses a critical need in pediatric endocrinology by offering improved dosing flexibility, once-daily administration, and enhanced treatment adherence for children living with Graves disease. It also helps reduce the risk of side effects associated with fluctuating drug levels.
• In October 2023, Teva Pharmaceuticals commenced clinical trials for a biosimilar version of propylthiouracil (PTU), a widely used antithyroid medication. The biosimilar is designed to increase global affordability and accessibility, particularly in emerging markets where treatment costs and drug availability remain barriers. If approved, this biosimilar could improve therapy equity and reduce dependence on expensive branded drugs.
• In July 2023, Pfizer announced its investment in a cross-border collaborative project involving academic institutions in the Asia-Pacific region to explore genetic biomarkers linked to Graves disease susceptibility and treatment responsiveness. This study supports Pfizer’s broader strategy in precision medicine, with the goal of identifying genotype-based predictors for optimal therapeutic responses. The project may unlock new insights into the pathophysiology of Graves disease across diverse populations.
